The present invention relates to an improve female urinary incontinence receptacle. More specifically the receptacle is formed with a polymer gel ring attached to the rim portion of the receptacle base. The gel ring which is made from a soluble silicon gel material provides a substantially leak-proof seal between the rim of the receptacle and the vulvar tissue of the user which it contacts.
Absorbent materials, e.g. pads and undergarments, and indwelling catheters are frequently used for treating urinary incontinence in females. Neither approach is suitable for extended periods of use or for females who while suffering from urinary incontinence otherwise lead normal active life styles, or who as a result of occupational circumstances cannot avail themselves of ordinary restroom facilities.
Absorbent pads are bulky, uncomfortable and non-hygienic. The pads must be changed frequently since urine trapped within is an excellent medium for the growth of microorganisms which can cause severe irritation and infection of sensitive skin which is in contact with the pad. Furthermore, there is also a significant risk of serious internal infection in absorbent pad users, particularly those who are bedridden.
Indwelling catheters likewise suffer from the disadvantage of causing irritation and internal infections. Moreover, catheterization is unsuitable for generally active females.
A preferred approach to female urinary incontinency involves the use of a cup-like receptacle which is designed so as to surround substantially the urogenital region and collect urinary discharge. Such receptacles are generally formed with an opening in the bottom to which is connected a drainage tube for transporting the urine to a suitable urine collection means, for example a bag secured to the leg of the user. The receptacles may vary in size with larger models externally surrounding the entire urogenital area, whereas smaller receptacles fit internally within the urogenital area, i.e., between the labia major, thereby surrounding essentially the urethral opening. The larger style of receptacle is generally held in place by means of a vaginal insert member affixed to the receptacle and a supporting garment. Smaller receptacles, which can be used internally, may be held in place by the labia major alone, an attached vaginal insert member, an adhesive, and/or a support garment.
Urine leakage, however, is a major problem with both the larger and smaller types of receptacles. The major reason for this problem is an inability of these devices to effect an essentially leak-resistant seal between the rim of the receptacle and the vulvar tissue which it contacts.
The rim portion of known female incontinence devices is generally smooth. Such smooth rim portions mate poorly with the irregular surface contours of the urogenital region and thus the devices are prone to urine leakage. Several attempts have been made to remedy this problem. For example, it has been taught in U.S. Pat. No. 4,198,979 to coat the smooth rim surface of the receptacle with a suitable adhesive which will bond the rim to the vulvar tissue. It has also been taught in the prior art to fabricate the receptacle from materials such as polymethacrylates which become pliant at body temperature and pressures to conform to the configuration of the vulvar tissues. See e.g. U.S. Pat. No. 4,270,539. However, it has been found that ethylpolymethacrylate, for example, hardens and loses its shape over time. It is also known that polymethacrylates can vary in shrinkage and resiliency by varying the polymer composition.
In fact, none of the devices disclosed in the prior art have provided an optimum seal so that urine leakage, along with associated irritation and infection, have continued to be major problems.
These problems are substantially eliminated by the present invention which provides for a urine receptacle having a deformable polymer gel attached to the rim portion which conforms to the vulvar contours to make an essentially leak-resistant seal.